Research study anti-pd-1 and KIR vs M3475 Expanded Access

Posted By
5/18/2014 11:24pm
View other posts by
Activity
Replies: 4

Short review:

husband 

July 2010 dysplastic nevi left calf

derm exams every 6 months

July 2013 bump lower left calf and enlarged left groin lymph node

August 2013 diagnosed stage 3c, groin lymphadenectomy 

October 2013 - December 2013 ipi Tx 4 cycles total (colitis treated with prednisone and 2 doses remicade)

Ringing in ears. brain MRI clear. February 2014

CT clear jan 2014

April 2014 PET show high SUVs calf , groin and stomach 

April 2014 Endoscopy with biopsy reveals 3.5 cm lesion in stomach that is melanoma

Meet with teams at mskcc and penn. Decide on BMS anti-pd1 and KIR trial.  To be begin this weds may 21st

My Question?

if husband fails trial, would he be eligible for expanded access MK3475? If you were ever on a Merck 3475 trial that would exclude you but would a BMS trial exclude you?

Lastly, when do you think the FDA will approved Anti pd 1?

 

thanks in advance. Anxious to get treatment moving but don't want to make the wrong move. 

 

 

BMS pd1 would not exclude you from Merck's EAP.  I read EAP got pushed to October of this year at the earliest. I start the EAP this Wednesday so I'm hoping for the best with it. If I could have made the 28 day washout of being off the taf/mek combo and the doctor would have accepted me with my back damage I would have gone for the BMS pd1/anti-kir or pd1/anti-lag-3. Then like you are thinking have the EAP as a backup plan.

It keeps surprising me that there are slots on the PD1/KIR trial, since the number of slots is 16 total for melanoma in the current cohorts. I have wondered if the news of the EAP would draw participants who might otherwise participate in lots of other trials. Maybe accrual now is much slower than I thought it would be.

​If I had the choice now of EAP vs. PD1/KIR I'm not sure which I would choose. I chose the first one that could get an IV in my arm.

Thanks to you both for feedback.  I think they may have added more spots or something to the Anti-PD1/KIR.  The PD1/KIR gets the IV in his arm this Weds.  So we are going for it.

Any ideas how they will follow the tumor in his stomach?  It makes me nervous and it seemed ulcerated so I just worry about perforation or something.  He is not losing weight so no issues there.  I forgot to put in original post.  BRAF neg/NRAS pos.  So Mek Inhibitors are backpocket. 

Again, Thanks...you all keep me off the ledge.

HD IL-2 should also be in your backpocket.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3241890/

"In the subset of patients for which mutational analysis was available, there was a significant difference in the response rate based on the mutation status: NRAS 47%, BRAF 23%, and WT/WT 12% (p=0.05). Patients with NRAS mutations had non-statistically longer overall survival (5.3 versus 2.4 years, p=0.30) and progression free survival (214 versus 70 days, p=0.13)."

I'm me, not a statistic. Praying to not be one for years yet.